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The Activator V-E is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.

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The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Activator V-E Spinal Adjusting Instrument." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain the kind of information typically associated with a study that proves a device meets acceptance criteria using performance metrics like accuracy, sensitivity, specificity, or F1-score. This type of information is usually found in detailed clinical study reports, scientific publications, or specific sections of a 510(k) submission that describe performance testing.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. It does not necessarily require the presentation of novel clinical performance data demonstrating specific quantitative acceptance criteria in the same way a de novo application or a premarket approval (PMA) might.

Therefore, I cannot extract the requested information from this document. It does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size for test sets or data provenance for performance studies.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for test sets.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. Type of ground truth used for such studies.
8. Sample size or ground truth establishment for a training set (as this is not an AI/ML device document).

The document is purely a regulatory clearance letter acknowledging substantial equivalence based on information submitted previously by the manufacturer, but the letter itself does not detail the specific performance studies.

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The Activator V is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.

The Activator V is a hand-held electromechanical chiropractic adjusting instrument with a plunger-like mechanism that is intended to be used for chiropractic adjustment of the spine and extremities. The device is only intended to be used by a health care professional licensed by the state in which he or she practices. The thrust is provided by battery power rather than manual force. This makes it easier and less tiring for the chiropractor.

Here's a breakdown of the acceptance criteria and study information for the Activator V, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document indicates that the device's performance aligns with the stated acceptance criteria: "The Activator V has been mechanically tested and shown to deliver approximately 75, 125, 175 or 250 N, depending on the selected thrust setting." The rechargeable battery's safety and performance were also confirmed through manufacturer testing.

Study Information

1. Sample size used for the test set and the data provenance: The document does not specify a separate "test set" in the context of clinical data for performance evaluation in humans. The performance data provided is related to mechanical testing of the device itself, not patient outcomes. Therefore, sample size and data provenance for a human test set are not applicable or provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is the physical output of the device (thrust force), established through mechanical testing, not by expert consensus on clinical data.

3. Adjudication method for the test set: Not applicable. As the performance relates to mechanical testing of force output, an adjudication method for a clinical test set is not relevant.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a chiropractic adjusting instrument; it is not an AI-powered diagnostic or interpretive tool that would involve human "readers" or an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself performs a standalone function (delivering thrust). The "performance data" provided refers to the mechanical output of the device without human intervention beyond selecting the thrust setting.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance claims (thrust delivery) is based on mechanical measurements of force output.

7. The sample size for the training set: Not applicable. The Activator V is a mechanical device, not an AI or algorithmic system that requires a "training set."

8. How the ground truth for the training set was established: Not applicable, as no training set is relevant for this device.

Ask a specific question about this device

Ask a specific question about this device